Director, Digital Systems Quality Assurance
Insmed Incorporated
7 months ago
Remote friendly (Bridgewater, NJ)
United States
IT
Director of Digital Systems Quality Assurance (DSQA)
Responsibilities:
- Establish, lead, and continuously improve quality oversight of GxP digital systems supporting clinical development/operations, data management, and biometrics.
- Ensure computerized systems, data integrity controls, and digital workflows meet global regulatory requirements, internal quality standards, and lifecycle management expectations.
- Oversee QA support for optimizing, troubleshooting, and maintaining key global/site GxP systems.
- Serve as QA lead for Computer Software Validation (CSV) lifecycle documents; facilitate IT Change Control; conduct QA review of CSV documents.
- Drive QMS processes, IT Change Control, Computerized System Validation, electronic data integrity, and monitoring/auditing of audit trails.
- Partner with business to evaluate stakeholder needs; ensure Data Integrity compliance; provide guidance on SDLC/validation and risk-based approach.
- Oversee implementation/validation of GxP software applications/modules and interfaces; support upgrades, change control, retrospective validation, and add-on installations.
- Ensure compliance with FDA/EMEA/PMDA requirements; write/maintain SOPs and quality documentation; support regulatory inspections and internal audits.
- Provide leadership via objective setting, performance appraisal, and development; deliver multiple projects.
Qualifications/Requirements:
- Bachelor’s degree; minimum 10 years QA experience (MS plus minimum 5 years considered).
- Experience in implementing/validating/maintaining/integrating electronic document and Quality Management in FDA or equivalent regulated settings.
- QA reviewer experience for GMP records/processes (CSV protocols, deviations, CAPA, SOPs, etc.).
- Required: experience with Veeva Clinical systems, IRT/eCOA, and Data Management software.
- Preferred: Data Integrity; 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile/Waterfall), CSA.
- Excellent verbal/written communication; project management; highly organized with strong attention to detail.
- Exhibit Insmed values: Passion, Accountability, Collaboration, Integrity, Respect.
Travel: ~30% domestic/international.
Work: Hybrid, Bridgewater, NJ headquarters.
Application instructions: Current Insmed employees apply via the Jobs Hub in Workday.
Responsibilities:
- Establish, lead, and continuously improve quality oversight of GxP digital systems supporting clinical development/operations, data management, and biometrics.
- Ensure computerized systems, data integrity controls, and digital workflows meet global regulatory requirements, internal quality standards, and lifecycle management expectations.
- Oversee QA support for optimizing, troubleshooting, and maintaining key global/site GxP systems.
- Serve as QA lead for Computer Software Validation (CSV) lifecycle documents; facilitate IT Change Control; conduct QA review of CSV documents.
- Drive QMS processes, IT Change Control, Computerized System Validation, electronic data integrity, and monitoring/auditing of audit trails.
- Partner with business to evaluate stakeholder needs; ensure Data Integrity compliance; provide guidance on SDLC/validation and risk-based approach.
- Oversee implementation/validation of GxP software applications/modules and interfaces; support upgrades, change control, retrospective validation, and add-on installations.
- Ensure compliance with FDA/EMEA/PMDA requirements; write/maintain SOPs and quality documentation; support regulatory inspections and internal audits.
- Provide leadership via objective setting, performance appraisal, and development; deliver multiple projects.
Qualifications/Requirements:
- Bachelor’s degree; minimum 10 years QA experience (MS plus minimum 5 years considered).
- Experience in implementing/validating/maintaining/integrating electronic document and Quality Management in FDA or equivalent regulated settings.
- QA reviewer experience for GMP records/processes (CSV protocols, deviations, CAPA, SOPs, etc.).
- Required: experience with Veeva Clinical systems, IRT/eCOA, and Data Management software.
- Preferred: Data Integrity; 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile/Waterfall), CSA.
- Excellent verbal/written communication; project management; highly organized with strong attention to detail.
- Exhibit Insmed values: Passion, Accountability, Collaboration, Integrity, Respect.
Travel: ~30% domestic/international.
Work: Hybrid, Bridgewater, NJ headquarters.
Application instructions: Current Insmed employees apply via the Jobs Hub in Workday.